Diethyl acetylsuccinate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 February - 6 June 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diethyl acetylsuccinate

EC Number:

214-223-8

EC Name:

Diethyl acetylsuccinate

Cas Number:

1115-30-6

Molecular formula:

C10H16O5

IUPAC Name:

1,4-diethyl 2-acetylbutanedioate

Details on test material:

- Name of test material (as cited in study report): "Diethylacetylsuccinate"- Physical state: Bright yellow liquid.- Lot/batch No.: SLBE 101- Solubility i nwater: ca. 15g/L- Melting point: -8 °C- Boiling point: 180 °C/67 mbar- Density: 1.081- Expiration date of the lot/batch: December 1999- Storage condition of test material: In the refrigerator, in the dark.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: J. Schitkovits, A-2620 Natschbach- Weight at study initiation: Animal No. 41: 3.2 kg, Animal No. 42: 3.2 kg, Animal No. 43: 2.9 kg- Weith at study termination: Animal No. 41: 3.4 kg, Animal No. 42: 3.2 kg, Animal No. 43: 2.9 kg- Housing: Optimal hygienic conditions, individual caging in metal wire cages, Ehret GmbH, type KK016R, 79 cm x 59 cm x 35 cm- Diet: Altromin 2023 diet for rabbtis, ad libitum.- Water: tap water from an automatical watering system, ad libitum.- Acclimation period: 6 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): average of 20 °C - Humidity (%): average of 54 %.- Air changes (per hr): 12 per hour.- Photoperiod (hrs dark / hrs light): 12 hrs dark, 12 hrs light.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL per animal

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after patch removal.

Number of animals:

3 females

Details on study design:

TEST SITE- Area of exposure: 2.5 cm x 2.5 cm at dorsal area of the trunk (dorsal thoracal region).- Type of wrap if used: Samples of the test substance were spread on cellulose patches and were applied to the test sites. They were held in place by fixing them marginally with non irritating tapes. The applicatio nsites were covered semi-occlusively by a dressing. Access by the animal to the application sites was prevented by a plastic collar.REMOVAL OF TEST SUBSTANCE- Time after start of exposure: duration of exposure was 4 hours. At the end of the exposure period the dressing, the tapes with the patches and the collar were removed, residual test substance was removed with wet Kleenex-tissues.SCORING SYSTEM:The treated ares and the surrounding untreated skin (control area) were examined for erythema/eschar and oedema as well as for other local signs 1, 24, 48 and 72 hours after patch removal.The skin was examined using a light source KL 1500 electronic. Dermal irritation was described and recorded according to the scoring scheme for acute dermal irritation/corrosion tests. (see below).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all 3 animals

Time point:

other: 1, 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all 3 animals

Time point:

other: 1, 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

All areas treated with the test substance and all control areas were normal before the application.Erythema/eschar: Not observed at any observation point.Oedema: Not observed at any observation point.

Other effects:

None

Any other information on results incl. tables

 

	Mean Scores for Animal No.:
	41	42	43
Erythema / Eschar:	0.0	0.0	0.0
Oedema:	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The test substance did not cause any adverse skin reactions in this study.

Executive summary:

Aim of the study

The aim of this study was to investigate possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits.

Methods

Methods and investigations were performed in accordance with the OECD Guideline 404 and the Directive 92/69/EC, method B.4.

Administration of the test substance

0.5 mL "diethylacetylsuccinate" was applied via a patch to a site of 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by a semi-occlusive dressing. The duration of the exposure was 4 hours.

Investigations

·      Body weights: at the start and at the termination of the test.

·      General signs of toxicity: once daily.

·      Skin examinations: 1, 24, 48 and 72 h after patch removal (p.a.).

Results

General signs of toxicity: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Skin examinations: All exposed skin sites were normal at each examination term.

Conclusion

The following mean scores were calculated for each animal from the examinations 24 h, 48 h and 72 h p.a.:

 

	Mean Scores for Animal No.:
	41	42	43
Erythema / Eschar	0.0	0.0	0.0
Oedema	0.0	0.0	0.0

 

The test substance did not cause any adverse skin reactions in this study.